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NCT01203488 · ClinicalTrials.gov registry record · Phase 1
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
A Phase 1 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 807
- Enrollment target
NCT01203488 is a Phase 1 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 807 participants.
The verdict
NCT01203488, a Phase 1 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 807 participants
- Enrollment target
Study Summary
This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.
Interventions
- OTHER Sham Procedure
- DRUG Vitamin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 807 participants |
| Start Date | 1996-01 |
| Est. Completion | 1999-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01203488
The ClinicalTrials.gov registry entry for NCT01203488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 807 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham Procedure is the first listed.
NCT01203488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01203488 about?
NCT01203488 is a clinical study titled "Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants". This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who ...
What is the current status of trial NCT01203488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 807 participants. The study started on 1996-01. Estimated completion is 1999-07.
What interventions are being tested in trial NCT01203488?
The interventions under investigation include: Sham Procedure (OTHER), Vitamin A (DRUG).
Who is sponsoring clinical trial NCT01203488?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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